Physiology of the Weight Reduced State
University of Pittsburgh
Summary
The goal of this clinical trial is to determine the physiological basis for the differences in weight regain among adults (25-59 years old) with obesity following participation in a behavioral weight loss program. Eligible participants will undergo a baseline evaluation after which they will enter an up to 20 week behavioral weight loss program with the goal of losing at least 7 percent of their baseline weight within 35 weeks. Participants who meet the weight loss goal will be asked to remain weight stable for 2 weeks after which they will undergo a clinical examination. They will then be observed for 1 year during which they will undergo 2 additional clinical examinations, one 4 months after completing the weight loss program, and the other 12 months after completing the weight loss program.
Description
Primary Hypothesis: Changes, integrated values and patterns in energy intake (EI), energy expenditure (EE), resting energy expenditure (REE) and non-resting energy expenditure (NREE), contribute to the variability in weight change during the 12 months following weight loss. Assessment time points: * Baseline (BL): prior to starting the weight loss intervention * T0: at the end of a period of weight stabilization following at least 7 percent weight loss * T4: four months (17 weeks) following T0 * T12: twelve months (52 weeks) following T0 Secondary Hypotheses: Changes, integrated values an…
Eligibility
- Age range
- 25–59 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age: 25 - \<60 years 2. BMI: 30 - \<40 kg/m2 at the first screening visit 3. Within 5% of current weight, for the past 6 months at the first screening visit 4. Able to participate in ergometry testing 5. Has a smart phone, tablet or computer with access to the internet Exclusion Criteria: 1. If 25-29 years old, \> 5% deviation from maximum weight (excluding weights while pregnant) since age 25 years 2. If at least 30 years old, \> 5% deviation from maximum weight (excluding weights while pregnant) in last 5 years or ≥ 10% deviation from maximum weight (excluding weigh…
Interventions
- BehavioralWeight loss
A behavioral lifestyle program, up to 20 weeks in duration, based on interventions shown to be successful for weight loss such as the Diabetes Prevention Program (DPP), Action for Health in Diabetes (Look AHEAD), and Comprehensive Assessment of the Long-term Effects of Reducing Intake of Energy Study (CALERIE). Weekly sessions, led by experienced interventionists, will provide education and behavioral strategies for weight loss focused an energy-reduced diet and physical activity. Participants must meet the following milestones to continue in the study: * ≥ 2% weight loss anytime between 28 and 34 days after the start of the intervention * ≥ 5% weight loss anytime between 140 and 146 days after the start of the intervention * ≥ 7% weight loss by the end of 35 weeks After achieving ≥7% weight loss followed by weight stability, participants are observed, without further intervention, for 52 weeks.
Locations (3)
- Columbia University Irving Medical CenterNew York, New York
- Drexel UniversityPhiladelphia, Pennsylvania
- University of PennsylvaniaPhiladelphia, Pennsylvania